Last Updated: 18 August 2026
Choosing a Representative: What Overseas Manufacturers Need Before CDSCO Filing
Selecting the Authorized Indian Agent is no less than a marriage: According to Indian rules and regulations, an overseas manufacturer can have more than one importer in India. In practice, the Authorized Indian Agent is different from having several importers.
MD-14 and MD-15: When an overseas manufacturer applies for an approval to sell their medical devices and IVDs in India, they have to get approval from the Indian health ministry, which is the CDSCO, under a licence called MD-14, and get an MD-15 import licence certificate.
SUGAM is restricted to locality: The process takes place through an online portal, which is known as SUGAM Portal, but this is only accessible by a local Indian entity. Therefore, for any entity to act as an agent, it must be a local Indian firm.
Who can be your Authorized Indian Agent?
Your own Subsidiary
Your own subsidiary that operates in the country.
Your Local Distributor
Your local distributor who is also your business associate.
Independent Authorized Indian Agent
Independent Authorized Indian Agent who is not your sales partner.
With the growing strictness of the rules, more and more firms are tending to opt for the third choice. Earlier, the distributors used to prefer the license.
What an Authorized Indian Agent must hold
An Authorized Indian Agent must be a company established in India holding an import export licence, which is an IE code. Either a wholesale drug licence which comes in Form 20B or 21B, or a medical device licence which is MD-42. Essentially, it should also have an account with the SUGAM portal, which is similar to how you need to have an eSubmitter account on US FDA.
Why Morulaa?
Morulaa is seeing a trend that both large established distribution firms in India, as well as smaller distribution firms which come under the SME category, prefer to tie up with Morulaa as the Authorized Indian Agent.
Whether you have a single large distributor or you have multiple distributors, there is an advantage to a three way relationship: the distributor focuses on sales, Morulaa as your Indian Authorized Agent focuses on keeping you compliant, and you provide the products.
We are also seeing an increased trend of distributors preferring to partner with Morulaa as an Indian Authorized Agent. Morulaa is known and is given recommendations and references due to its strong ethics, efficiency, and infrastructure in supporting the importation logistics and last mile delivery with its 4PL services. As Authorized Agent, Morulaa is independent, which means you do not need to share your sensitive data with multiple parties.
In 2025, our team successfully transitioned one Class C Ventilator manufacturer from the Distributor held licensing model to an Independent licensing model, completing all necessary procedures ASAP avoiding potential supply chain disruptions worth 3 months of continuous device supply.
How you appoint an Authorized Indian Agent
While appointing an IAA, there is a requirement of executing a Power of Attorney by the manufacturer. You must check whether you are a member of the Hague Convention (Apostille Convention). If yes, then the Power of Attorney can be apostilled, otherwise it has to be authenticated through the Indian Embassy.
Most Chinese manufacturers require only the Indian Embassy Authentication or First Class Magistrate from India to execute a POA.
Can you transfer the Indian Authorized Agent?
The Transfer of the same is not permissible. It can be only made through addition of a new fresh import licence.
Do not make a “handover” of the existing MD-15 from one authorized agent to another. CDSCO does not make any transfers. A new fresh import licence has to be added.
Why Manufacturers Choose Morulaa as Their Indian Authorized Agent (IAA)
Foreign companies that are looking to select an IAA will look out for organizations which have the capabilities of being a manufacturer level distributorship:
Largest Independent India Authorized Agent on SKUs (by 2026)
Over 2000 SKUs handled by IAA
The only Independent India Authorized Agent in India’s top 10 Importers based on unique MD-15 import license (by 2026)
Single point solution for all services related to IAA, registration, labeling and post market support
1. Approvals are getting tougher
As an IAA, Morulaa can cope with the constantly changing regulations. There have been trends where the CDSCO. is posing queries that are increasingly becoming more like those posed by the auditors at the notified body in Europe, which require specialized skills to answer these queries and get an approval.
It is evident from the publicly listed database of approved medical devices that the trend line is becoming flat. The reason behind this is that it is becoming increasingly difficult to get approval. This makes Morulaa, who is one of the highest independent license holders, best suited to deal with this situation.
2. Keep the file live with CDSCO
Any post approval modifications made in the documentation must be updated on a live basis through the government. Failing to do so, during the renewal process, which occurs after every five years, could lead to bottlenecks in getting your approval. Being a registered Indian Authorized Agent, Morulaa ensures that your file remains live and updated with the CDSCO. This does not happen only when the sales start to take off. It is important to note that it takes some time to get a foothold in the market.
3. Three way relationship: you, Morulaa, the distributor
Regardless of whether you work with one big distributor or with several distributors, the distributor’s concern is sales. Morulaa being your Indian Authorized Agent’s concern is that you remain compliant. You supply the products we keep the regulatory going.
Don’t wait until sales take off before updating your CDSCO file. The renewal process is every five years. Failure to record post approval amendments in real time means you find yourself in a bottleneck when the market starts picking up.
What CDSCO expects the Indian Authorized Agent to do
Filing of applications and other communications with the CDSCO
Technical help and guidance in the process of product registration and licensing
Guidance on compliance with the Medical Device Rules 2017
Mandatory reporting of adverse events when required by the CDSCO
How Morulaa acts as your IAA
Representation as an Indian Authorized Agent (IAA) in India
Guidance in classification and filing
Document preparation for the clearance of import license application MD-14/MD-15 for Medical Device
Responding to the queries from CDSCO based on their vast experience
Documentation for import and preparing files for CDSCO submission
Post market Surveillance and Supervision
For the full MD-14 to MD-15 pathway, grouping, fees and timelines, see India Medical Device Registration: CDSCO Compliance Guide.
FAQS
Do foreign manufacturers need an Indian Authorized Agent?
Yes. SUGAM is only accessible by a local Indian entity, which is similar to how you need to have an eSubmitter account on US FDA. The Authorized Indian Agent can be your own subsidiary, a local distributor who is also your commercial partner, or an independent Authorized Indian Agent.
What licence must an Authorized Indian Agent hold?
An Authorized Indian Agent must be a company established in India holding an import export licence, which is an IE code. Either a wholesale drug licence which comes in Form 20B or 21B, or a medical device licence which is MD-42. Essentially, it should also have an account with the SUGAM portal.
How do we appoint Morulaa as IAA?
A Power of Attorney has to be executed between the manufacturer and the Authorized Indian Agent. Check if you are a member of the Convention (Apostille Convention). If you are, this Power of Attorney can be apostilled. Else it needs to be authenticated by the Indian Embassy. Many Chinese manufacturers, when selling in India, require an Indian Embassy only, or they need to do a first class magistrate in India.
What does “only IAA in the top 10 MD-15 licences” mean?
Morulaa is India’s largest IAA by SKUs represented, with over 2000 SKUs under IAA representation as of 2026, and the only IAA in India’s top 10 Importers by unique MD-15 import licences as of 2026. Morulaa is the single largest independent licence holder.
Do you handle only IAA or can you assist with registration?
Both. One stop service for IAA, registration pathway, labelling, and post market support, including importation logistics and last mile delivery with 4PL services.
Why are distributors tying up with Morulaa instead of holding the licence themselves?
As the regulations are getting stricter, CDSCO queries are more and more similar to a European notified body auditor. Large established distribution firms and SME distributors prefer to tie up with Morulaa as the Authorized Indian Agent because of ethics, efficiency, infrastructure, and because Morulaa is independent you do not need to share your sensitive data with multiple parties.
What happens if the file is not kept live until renewal?
Post approval changes have to be recorded live with the government. If that is not done, at renewal every five years it can cause a bottleneck. Morulaa keeps your file live and updated with CDSCO, not just when sales are starting to pick up.
